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FDA Speeds Up Generic Approval Process

Healthcare has been in the spotlight for much of the year so far, as Congress has wrestled with the difficult question of how to make it both better and more affordable.

Because medications can be an especially costly aspect of healthcare, many people feel that making more generics available could significantly help with controlling costs. And it turns out that the new commissioner of the Food and Drug Administration, Dr. Scott Gottlieb, agrees.

When he was appointed, there was some concern that Gottlieb was too close to the pharmaceutical industry (“Gottlieb has received millions of dollars in compensation from some 20-odd biopharma and health firms,” reported Fortune Magazine in March of 2017). However, he quickly signaled his intent to take a more patient-first approach when the FDA announced a plan for getting generics to market faster.

“At a congressional budget hearing, Gottlieb said the FDA under his direction will publish and regularly update a list of medications that are off patent and have no competition,” explained Eric Sagonowsky of FiercePharma. “The agency will also seek to ‘curtail gaming’ of regulations; companies have used such workarounds to extend patent monopolies.” Meg Tirrell of CNBC also noted that Gottlieb announced an intention to streamline the review process for generics by getting rid of overlapping procedures that lengthen the time it takes to get a drug to market.

It is too early, of course, to judge what the results of the FDA’s efforts will be, but already there are some signs that things are looking up for generics. Sagonowsky reported that the Valeant medication Isuprel is already facing a “copycat” from Nexus Pharmaceuticals, which was just approved by the FDA. And the Regulatory Affairs Professionals Society has highlighted the fact that generic drug approvals are on the rise, with May and June of this year seeing record approval rates.

These trends will surely be pleasing to consumers who prefer to purchase less costly generic medications, but of course, it is also important that safety not is sacrificed in the process. This issue calls to mind the 2013 FDA proposal for generic drug labelling rule, which included the following:

“We are proposing to allow any ANDA holder to make certain safety-related labeling changes by submitting a CBE-0 supplement before the NDA holder has changed the labeling for the reference listed drug, so we must also consider the possibility that multiple ANDA holders may submit different CBE-0 supplements for the same safety concern (e.g., based on published literature) at approximately the same time.”

Although this proposal is still under discussion, the need for patient safety is clear (and all the more so with the renewed focus on generics). Also clear is that the FDA understands the critically important role of scientific literature in addressing safety concerns around generics. Constantly monitoring the literature to identify any potential problems surrounding these medications is, as Joyce de Langen suggests in this article, not just a time-consuming regulatory obligation, but a genuinely necessary measure for patient safety.

Maintaining high pharmacovigilance standards is not a simple task, but a vital one. And there are solutions available to “ease the pain,” as Neal Katz explains in this blog post on adverse drug event monitoring and the pharmacovigilance tool QUOSA. What’s more, Embase released in May a new search form – PV Wizard – that provides structured guidance and pre-coded search queries to support building a precise and effective PV search query. It simplifies the search building process and even novice users can build complex queries within minimal effort and time. (Learn more about literature monitoring best practices and using PV Wizard in this webinar.)

With the help of information tools such as these and ever-improving methods for keeping current with the literature, generic drug companies will be better able to provide safe and effective medications as they enjoy the advantages of the FDA’s speedier approvals process.